Glaucoma Studies |
Title: |
Prospective Biometric Study of Glaucoma Eyes Before and After Trabeculectomy Surgery |
| PI |
James D. Brandt, M.D. |
| Protocol #: |
200513230-4 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
After glaucoma surgery, some eyes become smaller because of the lower pressure that is caused by the surgery. We are interested in finding out what is different in those eyes that shrink more than others. We believe that some measurements, like the thickness of the cornea (the clear part of the eye) or an eyeglass prescription, might help us predict how eyes behave after surgery. |
| Indication: |
Subjects over 18 but less than 65 years of age with glaucoma scheduled to undergo a trabeculectomy surgery. |
| Contact: |
Katrina Imson (916) 734-6814 |
Cornea Studies: |
Title: |
Ocular Rosacea: Determining a Specific Diagnostic Test |
| PI: |
Mark J. Mannis, M.D. |
| Protocol #: |
200311634-7 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
To determine whether a new diagnostic tool can accurately provide a rapid, cost-effective test for early detection of ocular rosacea. This will potentially lead to considerably earlier treatment and the avoidance of complications that accrue from chronic ocular inflammatory disease. |
| Indication: |
Patients with ocular rosacea and with non-roseatic blepharitis, along with normal subjects. |
| Contact: |
Katrina Imson, 916-734-6814 |
Title: |
Keratoprosthesis in Severely Diseased Corneas |
| PI: |
Mark J. Mannis, M.D. |
| Protocol #: |
200311529-5 |
| Sponsor: |
Department of Ophthalmology along with Harvard University |
| Purpose: |
To implant either the keratoprosthesis Type I or Type II in severely diseased corneas to serve as an artificial cornea. Type I is for those who have experienced graft failure previously and Type II is for extremely dry eye. |
| Indication: |
Patients with severely diseased corneas where normal cornea transplants have been tried and failed. |
| Contact: |
Katrina Imson (916) 734-6814 |
Title |
Comparison of Preoperative Moxifloxacin (Vigamox) and Trimethoprim-Polymixin (Polytrim) Ophthalmic Drops on Normal Conjunctival Flora |
| PI: |
Vahid Feiz, M.D. |
| Protocol #: |
200715767-1 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
We want to obtain information that can help guide physicians in choosing pre-operative topical antibiotics for cataract and LASIK procedures. Study subjects will be randomized to one of two pre-operative topical antibiotics: Moxifloxacin 0.5% solution and Polytrim. Conjunctival cultures will be obtained before and after antibiotic use. The culture results will be analyzed in an attempt to identify a statistically significant difference between the two antibiotics’ effect on ocular flora. |
| Indication: |
Patients who are scheduled for cataract or LASIK surgery for any medically necessary indication. |
| Contact: |
Katrina Imson, 916-734-6814 |
Retina Studies: |
Title: |
A 3-Year, Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial to Assess the Safety and Efficacy of 700 g Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Diabetic Macular Edema (Protocol 206207-010) |
| PI: |
Susanna S. Park, M.D., Ph.D. |
| Protocol #: |
200513428-3 |
| Sponsor: |
Allergan |
| Purpose: |
The purpose of this study is to investigate the safety and effectiveness of Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in the treatment of diabetic macular edema. The DEX PS DDS will deliver dexamethasone to the back of the eye by way of an Applicator System which is a sterile, single use instrument shaped like a pen with a needle on one end. The DEX PS DDS slowly releases dexamethasone and dissolves over time. |
| Indication: |
The subjects will have diabetic macular edema in at least one eye. |
| Contact: |
Katrina Imson (916) 734-6814 |
Title: |
Histologic and Immunohistologic Evaluation of Pre-Retinal Membranes |
PI |
David G. Telander, M.D., Ph.D. |
| Protocol #: |
200513750-3 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
To collect the pre-retinal membranes (surgical specimen) from patients having standard-of-care surgery for proliferative vitreoretinopathy, macular pucker, and diabetic fibrovascular membranes to understand how these membranes develop so we can design methods to prevent the vision loss they cause. |
| Indication: |
Patients scheduled for a vitrectomy surgery for either proliferative vitreoretinopathy, macular pucker, or diabetic fibrovascular membranes. |
| Contact: |
Katrina Imson (916) 734-6814 |
Title: |
The Effects of Diabetes on Viscosity in Conjunctival and Retinal BloodVessels |
PI |
David G. Telander, M.D., Ph.D. |
| Protocol #: |
200614571-3 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
The purpose of this study is to compare the flow of blood in conjunctival and retinal vessels in diabetic patients compared to normal patients. |
| Indication: |
Subjects 18 years of age or older with: Advanced diabetes, moderate diabetes, subclinical diabetes, no diabetes (normal, age-matched volunteers). |
| Contact: |
Katrina Imson (916) 734-6814 |
Title: |
Assessment of Pathways and Genes Associated with Age-Related Macular Degeneration |
| PI: |
Lawrence S. Morse, M.D., Ph.D. |
| Protocol #: |
200715407-1 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
Blood samples will be collected to: 1) identify molecules in the blood that may be markers of age-related macular degeneration and other forms of AMD, 2) to isolate and examine properties of white blood cells that may be associated with these conditions, 3) to identify genes and mutations within these genes that may cause these diseases, 4) to identify diseases in other parts of the body that are associated with various forms of macular degeneration, 5) and to examine the clinical and biological relationships between AMD, other forms of macular degeneration and diseases in other parts of the body. |
| Indication: |
Patients who have been diagnosed with age-related macular degeneration. |
| Contact: |
Katrina Imson (916) 734-6814 |
Title: |
A Phase III, Double-Masked, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus |
| PI: |
Susanna S. Park, M.D., Ph.D. |
| Protocol #: |
200715664-1 |
| Sponsor |
Genentech, Inc. |
| Purpose: |
To 1) evaluate the efficacy of intravitreal injections of ranibizumab administered monthly for 24 months compared with sham control in the improvement of visual acuity (sharpness of vision), and 2) evaluate the safety and tolerability of intravitreal injections of ranibizumab administered monthly. |
| Indication: |
Patients with CSME-CI (Clinically Significant Macular Edema with Central Involvement) secondary to diabetes mellitus (Type 1 or 2). |
| Contact: |
Cindy Wallace (916) 734-6393 |
Title: |
Comparison of AMD Treatment Trials (CATT): Lucentis® - Avastin® Trial |
| PI: |
Susanna S. Park, M.D., Ph.D. |
| Protocol #: |
200715891-1 |
| Sponsor: |
National Eye Institute - University of Pennsylvania, Coordinating Center |
| Purpose: |
Determine the relative safety and efficacy of Lucentis® versus Avastin®, on either a fixed or variable dosing schedule, for treatment of neovascular (“wet”) age-related macular degeneration. |
| Indication: |
Patients who are 50 years of age or older, with newly diagnosed, previously untreated, active subfoveal choroidal neovasuclarization lesions secondary to age-related macular degeneration. |
| Contact: |
Helen Metzler (916) 734-6302 |
Title: |
Comparison of Macular Thickness and Morphology Among Commercially Available Fourier-domain Optical Coherence Tomography Units |
| PI: |
Susanna S. Park, M.D., Ph.D. |
| Protocol #: |
200816218-1 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
We are going to compare the optic nerve and macular thickness measurement using four new commercially-available Fourier-domain optical coherence tomography (Fd-OCT) units with the current standard-of-care Stratus OCT. |
| Indication: |
Patients being seen in the Neuro-ophthalmology and Retina clinics for macular or optic nerve pathology who need an OCT image of the macula (back of the eye) as standard of care will be considered for enrollment into this study. All testing will be done on the same day and will take about 45 minutes. |
| Contact: |
Marisa Salvador (916) 734-6681 |
Title: |
Bacterial Cultures of Needles Used for Intravitreal Injections |
| PI: |
David G. Telander, M.D., Ph.D. |
| Protocol #: |
200816279-1 |
| Sponsor: |
Department of Ophthalmology |
| Purpose: |
We want to find out whether bacteria that live on the eye’s surface are being introduced into the eye in the course of an injection. Sometimes patients get infections after injections and we would like to find out more about the possible sources of these infections. |
| Indication: |
Patients being seen in the Retina Clinic who are undergoing treatment for Age-Related Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion, or other retinal diseases, with injections of either ranibizumab (Lucentis®) or bevacizumab (Avastin®). |
| Contact: |
Cindy Wallace (916) 734-6393 |
Pediatric Studies: |
Title: |
A Randomized Trial to Evaluate 8 Hours of Daily Patching Plus Daily Atropine for Residual Amblyopia in Children 3 to < 8 Years Old (A11) |
| PI |
Mary O’Hara, M.D. |
| Protocol #: |
200715683-1 |
| Sponsor: |
National Eye Institute |
| National Eye Institute |
This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to <8 years with visual acuity of 20/32 to 20/50 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (8 hours of daily patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia. |
| Indication: |
Children age 3 to less than 8 years old who have been diagnosed with amblyopia associated with strabismus, anisometropia, or both. |
| Contact: |
Dr. O’Hara, via Barbara Holderreed (916) 734-6303 |
| |
Enrollment to commence in September, 2008 |
Title: |
Central Corneal Thickness Study (CCTS): A Prospective Study of Corneal Thickness in Children Less Than 18 Years Olds |
| PI |
Mary O’Hara, M.D. |
| Protocol #: |
200816334-1 |
| Sponsor: |
National Eye Institute |
| Purpose: |
This study is designed to determine the normal cornea (clear layer forming the front of the eye) thickness among various pediatric age groups and races. We are also trying to find out when the corneal thickness measurements in a child reach the adult thickness. Finally, we want to compare two different ways of measuring eye pressure using two different instruments that are already commonly used to measure eye pressure. We hope to determine normal eye pressure measurements among children and different races which may help avoid errors in diagnosing and treating glaucoma. |
| Indication: |
Children age 0 to less than 18 years old who are in Dr. O’Hara’s pediatric clinic for a routine ophthalmic exam or are in the operating room for patient care purposes. |
| Contact: |
Dr. O’Hara, via Barbara Holderreed (916) 734-6303 |
Eye Conditions
